CompletedNot Applicable

Mindfulness-Based Relapse Prevention to Improve Medication Assisted Treatment Adherence and Drug-use Outcomes for Opioid Use Disorder

United States105 participantsStarted 2021-08-01

Plain-language summary

This proposal aims to determine whether an adjunctive Mindfulness-Based Relapse Prevention (MBRP) treatment program improves Medication Assisted Treatment (MAT) adherence and reduces drug-use among opioid use disorder (OUD) patients. The broad long-term objectives of this project are to investigate how integrative pharmacological and behavioral treatments improve OUD treatment outcomes. This study aims to include 200 patients diagnosed with with opioid use disorder (OUD), that are enrolled in a \~60-day residential addiction treatment program. Participant recruitment will prioritize participants that are prescribed MAT for OUD. Participants will be randomly assigned to a MBRP behavioral treatment condition or a non-MBRP treatment-as-usual (TAU) control condition as part of their treatment within the residential addiction treatment program. All participants will be monitored for three-months following their discharge from the program to test the hypotheses that MBRP participants, relative to TAU participants, will (1) demonstrate greater MAT adherence following discharge, and (2) evidence reduced drug-use following discharge.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. An informed consent document voluntarily signed and dated by the subject.
. Subject must understand and be able to read and write in English.
. Enrollment in residential treatment at study site.
. Physically healthy males and females, aged 18 or older, who meet criteria for opioid use disorder (based on Diagnostic and Statistical Manual 5th Edition criteria) as their primary diagnosis, who are enrolled in residential treatment at the collaborating study site.
. Subject must be willing to be randomized to treatment condition.
. Subjects who are willing and able to comply with scheduled visits and other study procedures.

Exclusion criteria

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Adherence to Medication Assisted Treatment (MAT)

Timeframe: Assessed 1 month following discharge from residential addiction treatment facility (approximately 30 days post-discharge).

Adherence to Medication Assisted Treatment (MAT)

Timeframe: Assessed 2 months following discharge from residential addiction treatment facility (approximately 60 days post-discharge).

Adherence to Medication Assisted Treatment (MAT)

Timeframe: Assessed 3 months following discharge from residential addiction treatment facility (approximately 90 days post-discharge).

Opioid Drug Use

Timeframe: Assessed 1 month following discharge from residential addiction treatment facility (approximately 30 days post-discharge).

Opioid Drug Use

Timeframe: Assessed 2 months following discharge from residential addiction treatment facility (approximately 60 days post-discharge).

Opioid Drug Use

Timeframe: Assessed 3 months following discharge from residential addiction treatment facility (approximately 90 days post-discharge).

Trial details

NCT IDNCT05042388

SponsorWest Chester University of Pennsylvania

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-08-20

Results submitted2026-01-06

View on ClinicalTrials.gov More Opioid-use Disorder trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. An informed consent document voluntarily signed and dated by the subject.
. Subject must understand and be able to read and write in English.
. Enrollment in residential treatment at study site.
. Physically healthy males and females, aged 18 or older, who meet criteria for opioid use disorder (based on Diagnostic and Statistical Manual 5th Edition criteria) as their primary diagnosis, who are enrolled in residential treatment at the collaborating study site.
. Subject must be willing to be randomized to treatment condition.
. Subjects who are willing and able to comply with scheduled visits and other study procedures.

Exclusion criteria

What they're measuring

Adherence to Medication Assisted Treatment (MAT)

Timeframe: Assessed 1 month following discharge from residential addiction treatment facility (approximately 30 days post-discharge).

Adherence to Medication Assisted Treatment (MAT)

Timeframe: Assessed 2 months following discharge from residential addiction treatment facility (approximately 60 days post-discharge).

Adherence to Medication Assisted Treatment (MAT)

Timeframe: Assessed 3 months following discharge from residential addiction treatment facility (approximately 90 days post-discharge).

Opioid Drug Use

Timeframe: Assessed 1 month following discharge from residential addiction treatment facility (approximately 30 days post-discharge).

Opioid Drug Use

Timeframe: Assessed 2 months following discharge from residential addiction treatment facility (approximately 60 days post-discharge).

Opioid Drug Use

Timeframe: Assessed 3 months following discharge from residential addiction treatment facility (approximately 90 days post-discharge).